[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Universidade Cesumar (UNICESUMAR)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100658915","wb-ems-combined-with-nutritional-guidance-for-a-high-protein-diet-on-body-composition-muscle-function-psychological-and-functional-outcomes-in-older-adults-with-excess-adiposity-100658915",false,"NCT07859072","WB-EMS Combined With Nutritional Guidance for a High-Protein Diet on Body Composition, Muscle Function, Psychological and Functional Outcomes in Older Adults With Excess Adiposity","Effects of Whole-Body Electromyostimulation Combined With Nutritional Guidance for a High-Protein Diet on Body Composition, Muscle Function, Functional Performance, Psychological Outcomes, Cardiometabolic Health, Cognitive Function, Quality of Life, and Other Health Outcomes in Older Adults With Excess Adiposity: A Randomized Controlled Trial","WB-EMS","Inclusion Criteria:\n\n* Age 60 years or older (both sexes);\n* Body Mass Index (BMI) ≥ 25 kg\u002Fm² (overweight or obese);\n* Physically inactive (not engaged in regular structured exercise for at least 6 months prior to the study);\n* Medical clearance to engage in progressive resistance exercise and neuromuscular electrical stimulation.\n\nExclusion Criteria:\n\n* Presence of electronic implants (e.g., cardiac pacemakers, defibrillators) or metallic implants that contraindicate WB-NMES;\n* Absolute contraindications to WB-NMES (e.g., active neoplasia, severe epilepsy, acute inflammatory diseases, severe cardiac arrhythmias, thrombosis);\n* Severe cognitive impairment that prevents understanding instructions or questionnaires;\n* Disabling musculoskeletal or neurological disorders that hinder exercise performance;\n* Uncontrolled chronic diseases (e.g., uncontrolled hypertension or diabetes);\n* Current use of medications or supplements known to significantly affect protein metabolism or muscle mass;\n* Adherence below 85% in training sessions or nutritional follow-ups during the study period.","ALL","60 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a 16-week randomized controlled trial (RCT) with outcome assessor blinding. The objective is to investigate the effects of resistance training (RT) combined with whole-body neuromuscular electrical stimulation (WB-NMES) and a high-protein diet on body composition, anthropometry, and quality of life.\n\nSample and Group Allocation\n\nThe sample will comprise 36 older adults (≥ 60 years), physically inactive, and with overweight or obesity (BMI ≥ 25 kg\u002Fm²). They will be randomized (stratified by sex) into four groups of 9 participants:\n\nRT + NOR: Resistance training + normal-protein diet.\n\nRT + PRO: Resistance training + high-protein diet.\n\nWB-NMES + RT + NOR: Resistance training with electrical stimulation + normal-protein diet.\n\nWB-NMES + RT + PRO: Resistance training with electrical stimulation + high-protein diet.\n\nIntervention Protocol\n\nExercise (2x\u002Fweek, 25 min\u002Fsession): Seven exercises (2 sets of 1 min execution with 45s of rest). Progressive intensity controlled by the OMNI-RPE Scale.\n\nElectrical Stimulation (WB-NMES Groups): Simultaneous use of an electrode suit (85 Hz, 400 µs pulse width, 5s on\u002F5s off duty cycle), with intensity capped at a maximum of 5\u002F10 on the pain\u002Fdiscomfort Visual Analog Scale (VAS).\n\nNutrition (In-person + Remote): High-protein (PRO) groups will focus on an intake of 1.2 to 1.5 g of protein\u002Fkg\u002Fday. Normal-protein (NOR) groups will receive general healthy eating guidelines, without encouraging an increase in protein intake.\n\nAssessments and Outcomes (Conducted at T0 and T16)\n\nBody Composition and Anthropometry: Multi-frequency bioelectrical impedance (InBody 570) and circumference measurements following ISAK guidelines.\n\nPhysical and Functional Performance:\n\nHandgrip strength (dynamometry).\n\nMuscular endurance (30-second chair stand and arm curl tests).\n\nUpper limb power (2 kg medicine ball throw).\n\nAerobic endurance (6-Minute Walk Test).\n\nMobility and fall risk (Timed Up and Go - TUG).\n\nQuestionnaires and Scales:\n\nSelf-reported functional disability (WHODAS 2.0).\n\nBasic psychological needs satisfaction (BPNES).\n\nMotivational regulation in exercise (BREQ-3).\n\nQuality of life specific for older adults (WHOQOL-OLD).\n\nAdherence: Minimum attendance goal of 75% for the sessions.\n\nStatistical Analysis The analysis will follow the intention-to-treat (ITT) principle. Data will be analyzed using Linear Mixed Models for Repeated Measures (fixed factors: Group and Time), followed by Tukey's post-hoc test, adopting a significance level of $p \\\u003C 0.05$.",[27,28,29],"Overweight (BMI > 25)","Obesity & Overweight","Aging",[31,32,33,34,35,36,37,38],"Whole-body neuromuscular electrical stimulation","Resistance training","High-protein diet","Body composition","Older adults","WB-NMES","Muscle mass","Quality of life","NOT_YET_RECRUITING","2026-09-29",{"date":42,"type":43},"2026-10-05","ACTUAL",{"date":45,"type":21},"2026-10-02",{"date":47,"type":21},"2027-06-20",{"name":49,"class":50},"Universidade Cesumar (UNICESUMAR)","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":51},"100656039","multimodal-intervention-for-weight-management-and-health-in-the-elderly-population-100656039","NCT07820774","Multimodal Intervention for Weight Management and Health in the Elderly Population","Interdisciplinary Approaches to Managing Excess Weight and Promoting Health in Older Adults: a Multimodal Intervention","Inclusion Criteria:\n\n* Age ≥ 60 years;\n* Presence of excess adiposity\u002Foverweight or obesity, according to protocol criteria;\n* Medical clearance to perform supervised physical exercises and the tests;\n* No regular participation in structured resistance training over the past 5 months.\n\nExclusion Criteria:\n\n* Contraindication to resistance training or physical testing;\n* Unstable or uncontrolled cardiovascular disease;\n* Recent (\\\u003C 6 months) coronary or cerebrovascular event;\n* Uncontrolled arterial hypertension;\n* Untreated secondary\u002Fendocrine causes of obesity;\n* Use of medications that significantly alter body mass or composition;\n* Current use of anti-obesity medication, including GLP-1 agonists;\n* History of bariatric surgery or scheduled procedure;\n* Active weight loss process or weight fluctuation \\> 5% in the last 6 months.",{"count":60,"type":21},54,[24],"Aging may be accompanied by changes in body composition, muscle strength, metabolic health, and well-being. In older adults with overweight or obesity, strategies that combine physical exercise, behavioral changes, and nutritional guidance may contribute to better health and the maintenance of healthier habits.\n\nThis study aims to investigate the effects of a 16-week intervention combining resistance training, group cognitive behavioral therapy, and nutritional guidance for a higher-protein diet. Changes in body composition, muscle strength and function, vascular and metabolic health, cognitive function, psychological outcomes, quality of life, autonomy, self-care, and motivation for exercise and changes in eating habits will be assessed.\n\nThe study will include adults aged 60 years or older who have low levels of physical activity and excess body fat. Participants will be randomly assigned to one of three groups. The first group will receive resistance training only; the second group will receive resistance training plus group cognitive behavioral therapy; and the third group will receive resistance training, group cognitive behavioral therapy, and nutritional guidance for a higher-protein diet. This comparison will help determine the effects of each additional component of the intervention.\n\nResistance training will be performed three times per week. Group cognitive behavioral therapy sessions will be held weekly and will address strategies to support sustainable behavioral changes, including self-awareness, goal setting, the relationship between thoughts, emotions, and behaviors, problem-solving, and maintenance of behavioral changes. Nutritional guidance will also be provided in weekly group sessions, focusing on the sustainable adoption of a higher-protein diet using commonly consumed foods while considering participants' individual circumstances and autonomy.\n\nAssessments will be conducted before and after the 16-week intervention to evaluate potential changes associated with the interventions. Comparing the three groups will help determine whether adding psychological and nutritional strategies to resistance training provides additional benefits for the physical, metabolic, cognitive, and psychological health of older adults with overweight or obesity.",[28],[65,66,67,68,69,70],"obesity","aging","resistance training","high-protein diet","cognitive-behavioral therapy","self-determination","2026-09-10",{"date":73,"type":43},"2026-09-15",{"date":75,"type":21},"2026-09-14",{"date":77,"type":21},"2027-08-05",{"name":49,"class":50},""]